· BICX104 was Well Tolerated with No Serious Adverse Events Reported and Achieved 84 Days of Therapeutic Naltrexone Plasma Concentrations
· BICX104 Subjects Experienced Better 84-Day Treatment Adherence Than Vivitrol® Subjects
· Company Seeking FDA Approval for Immediate Expanded Access “Compassionate Use” of BICX104 for Over 10 Million Americans with Opioid Use Disorder
· BioCorRx Applying for Fast Track Designation and Also Seeking FDA Pre-NDA Meeting to Confirm Final Pathway for Regulatory Approval
Anaheim, CA - (NewMediaWire) - March 7, 2023 - BioCorRx Inc. (OTCQB: BICX) (the “Company”), a clinical-stage developer and provider of innovative treatment programs for substance use and related disorders, has announced interim positive safety and pharmacokinetic (PK) results for the Phase I clinical trial of the Company’s BICX104 implantable naltrexone pellet. Dr. Andrew P. Mallon, PhD, the principal investigator of BioCorRx’s Phase I study, funded by the National Institute on Drug Abuse (NIDA) through the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, presented the interim findings on February 21, 2023, at the 4th Annual HEAL Investigator Meeting.
Dr. Mallon commented, “While this is a small safety and pharmacokinetic study in healthy volunteers, the data show that BICX104 is well-tolerated, with no serious adverse events, and provided subjects with 84 days of therapeutic levels of naltrexone.”
Dr. Mallon continued, “We look forward to a few remaining subjects completing their final follow-up visits and the study completing on March 22nd, 2023. These results confirm our expectations that BICX104 naltrexone pellets can be implanted without a significant risk of safety complications.”
Dr. Mallon expects to submit a paper summarizing the Phase I clinical trial results of BICX104 to a peer-review journal later this year.
Based on the promising results of the Phase I study, BioCorRx expects to seek approval from the FDA to provide BICX104 under an “expanded access” treatment protocol through existing specialist centers that have experience in providing extemporaneously compounded naltrexone implantable products, as well as those experienced in treating their patients with other forms of naltrexone after detoxification. An expanded access treatment protocol is a pathway for patients with serious or immediately life-threatening conditions to gain access to an investigational medical product (drug, biologic, or medical device) that has not yet received full FDA approval but can be used for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
“The opioid overdose epidemic, causing an estimated 80,816 overdose deaths in 2021, almost doubling from roughly 42,000 in 2016[i], is such a significant and deepening public health crisis that BioCorRx believes it is urgent to help patients and prescribers as soon as possible by making BICX104 available to them under the expanded access program. We are encouraged that the FDA, on average, determines that 99% of all expanded access requests can proceed[ii]. Moreover, the FDA responds to expanded access requests within 30 days,” said Brady Granier, President of BioCorRx, Inc., Director of BioCorRx, Inc., and CEO of BioCorRx Pharmaceuticals, Inc.
BioCorRx is compiling the data and drafting its Pre-NDA Briefing Book and final NDA-enabling steps in anticipation of a pre-NDA meeting with the FDA. Additionally, the Company would separately apply for “Fast Track Designation” for BICX104 to expedite the approval process at the FDA.
BICX104 clinical study is a Phase I, 6-month, open-label, multi-center study in parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and Vivitrol® intramuscular depot naltrexone injection. Twenty-four male and female healthy volunteer subjects were randomized in a 1:1 ratio of both gender and study treatment arm: 12 subjects were administered BICX104 (3-month naltrexone pellets) and 12 subjects were to receive three consecutive 1-monthly naltrexone IM (intramuscular) injections (Vivitrol®). Information about the Phase I study can also be found at www.clinicaltrials.gov under NCT number 04828694.
BICX104 is being developed through a Cooperative Agreement with the NIDA, part of the NIH, under award number 3UH3DA047925-03S, funded by the Helping to End Addiction Long-term (HEAL) Initiative. This award is subject to the Cooperative Agreement Terms and Conditions of Award as set forth in “RFA DA-19-002” entitled, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)”.
The Helping to End Addiction Long-term (HEAL) Initiative, or NIH HEAL Initiative, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit https://heal.nih.gov.
Interim Data Highlights:
· The Vivitrol study arm witnessed pronounced study non-compliance with six subjects voluntarily discontinuing treatment: four subjects after one Vivitrol injection; one subject after two Vivitrol injections and one subject after three Vivitrol injections. A seventh subject was terminated due to a positive drug urine screen. Five subjects completed the study
· An interim assessment of the Proportion of Days Covered (PDC) by all study subjects except one that was involuntarily terminated observed that there were more highly adherent (>80%) to BICX104 (91.6%; n=12) than Vivitrol (54.5%; n=11)
· Subcutaneous implantation of BICX104 pellets was achieved using a simple, 15 minute, out-patient procedure undertaken by a physician, Board Certified in Internal Medicine, specialized in addiction treatment and with background in urgent care
- Study comprised of an initial 84-day treatment period with follow-up period over days 85 to 168. Study completes on March 22nd, 2023
- Eight subjects completed BICX104 and provided sufficient evaluable subjects for this interim PK and safety assessment:
- BICX104 was generally well-tolerated with no serious adverse events
- Only mild adverse events were reported and these were largely limited to local reactions related to the implantation or procedure: itching (3), redness (7), swelling (2), pain (1), and tenderness (1). Two subjects reported loss of appetite and one of them also reported a loss of taste that was not unexpected due to reduction in cravings that naltrexone can elicit. One report of mild shortness of breath
- All AEs were transient and resolved
- BICX104 Interim PK data (mean ± standard deviation) reported naltrexone Cmax 19.91 ± 7.09 ng/ml at a consistent Tmax 12 hours. AUC0-∞ 799.3 ± 110.18 day*ng/ml
- Steady state naltrexone concentrations (Cday ± SD) included C28: 11.32 ± 2.42 ng/ml (n=7); C56: 6.85 ± 1.33 ng/ml (n=8); C84: 1.69 ± 1.13 ng/ml (n=7); C91: 0.82 ± 0.91 ng/ml (n=8)
- The last observed day of naltrexone concentrations above the Opioid Use Disorder and Alcohol Use Disorder therapeutic level of 1 ng/ml was Day 84
Poster session details:
Title: “BICX104 Phase 1 Clinical Trial Results: Safe and Effective Naltrexone Implant for Chronic Prevention and Treatment of Opioid Use Relapse”
Abstract Number: 405
Session Information: Date and Time: February 21-22, 2023, Presenter: Dr. Andrew P. Mallon, Ph.D
Corporate Contact/Clinical Trial Sponsor: BioCorRx, Inc, 2390 East Orangewood Avenue, Suite 500, Anaheim, California 92806, Corporate Contact: Brady Granier: email@example.com.
Required Disclaimer: Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UH3DA047925. The content of this release is solely the responsibility of BioCorRx and does not necessarily represent the official views of the National Institutes of Health.
BioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction
Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile
app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication assisted weight loss
program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts and personal support from behavioral experts; please visit www.uncraverx.com for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com.
Safe Harbor Statement
The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become,"
"plan," "will," and similar expressions. These forward-looking statements involve known and unknown, risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.
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Source: BioCorRx Inc
[i] Substance Abuse and Mental Health Services Admin. (SAMHSA). Misuse opioids in US (Total Addressable Market) Dec 2022.
[ii] FDA Website: https://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data.
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